A medical device distributor has filed a libel claim against FairWarning, the consumer group Public Citizen and several other parties, claiming they made false statements about the company’s sales of a fat-melting device called the Lipotron 3000.
The complaint filed in Fort Worth, Tex., by Advanced Aesthetic Concepts, LP states that a July 11 FairWarning article about unauthorized LipoTron sales was inaccurate and has caused economic harm to the company and its top executive, Mark Durante.
It also states that, following publication of the article, Public Citizen defamed Advanced in letters urging the U.S. Food and Drug Administration and state medical boards to take enforcement action.
Fat-Melting Device a Weighty Matter for FDA
Filed Aug. 22 in Tarrant County District Court, the suit also targets two whistleblowers who provided information to FairWarning and Public Citizen, and Medical Spa MD, a blog that has followed the controversy.
Along with unspecified damages, Advanced is seeking a court order to bar the defendants “from making, speaking, creating, commenting, or writing, anything about Advanced, Mr. Durante, the LipoTRON 3000, the Lipo-EX Program.’’
Allison Zieve, general counsel of Public Citizen, said documentation obtained by her group “supports the truth of the statements in the Public Citizen letters.” She said she expects to seek dismissal under a Texas law banning SLAPP suits — or strategic lawsuits against public participation — “because the suit seeks to stifle speech about a matter of public concern.”
The LipoTron device for several years has been promoted by doctors and medical spas as a revolutionary way for people to slim down. Designed to eliminate fat with radiofrequency waves, rather than through invasive surgery, it is distributed by Advanced and manufactured by RevecoMED International of Fullerton, Calif.
The libel claim, which expands an existing lawsuit against one of the whistleblowers, says the defendants have made several false statements, including that the LipoTron has been marketed without FDA approval, and that the agency is conducting an investigation. It also says defendants inaccurately equated the Lipo-Tron with the Lipo-Ex program — which includes several treatments and devices, including the LipoTron, that Advanced markets to doctors and medical spas.
Interviews and documents reviewed by FairWarning, however, indicate that the FDA is investigating LipoTron sales. The agency has declined comment, citing a policy not to discuss investigations or confirm if there is one.
As reported by FairWarning, the LipoTron has never been cleared or approved by the FDA for weight-loss treatments, which would make it illegal to market it for that purpose. In 2011–several years after sales commenced–the LipoTron was registered with the FDA for a different use.
Reveco, the manufacturer, tried unsuccessfully in 2007 and 2009 to get FDA clearance, which requires showing that a device is similar in safety and effectiveness to others already on the market. In September, 2011, the Texas State Department of Health Services issued a warning letter to Advanced for marketing the LipoTron without an FDA clearance.
About the same time, Reveco registered the LipoTron as an electronic massager. Calling it a massager made it, in FDA parlance, a Class 1 device — a category that includes such low-risk items as elastic bandages, and bypasses agency review.
According to the Advanced lawsuit, since the Lipotron had a Class 1 registration, statements by the defendants about its approval status were false (The Class 1 registration was noted in the FairWarning article.).
The FDA has been aware of the situation at least since January, 2010, when the whistleblower- defendants—one a former LipoTron distributor– provided sales records and other documents to an agency investigator.
The lawsuit charges Paige Peterson, the former distributor, and Belinda Worley, a marketing consultant, with leading “a smear campaign’’ to cause financial harm to Advanced and Durante, including by disparaging them on the Internet and through social media.
Peterson denied that she has slandered the company. “The proof’s in the pudding,” she said. “It will all come out.”
As a LipoTron distributor from 2007 to 2009, Peterson acknowledged that she had sold dozens of the devices despite knowing they lacked FDA clearance. “All of this started with me turning myself in for my culpability with all this,” she said.
The libel claims expand a previous business dispute between Durante and Peterson.
In 2009, Reveco dropped Peterson and made Advanced its lead Lipotron distributor. A few months later, Advanced sued Peterson to recover more than $60,000 that Advanced had inadvertently wired to Peterson’s bank account, but that she refused to return.
A Fort Worth judge ruled in favor of Advanced, ordering Peterson to return the money. She had filed for bankruptcy, however, and did not repay the funds. The Advanced lawsuit remained dormant until last week, when it was amended to add libel claims against FairWarning and the other defendants.